Posts tagged with: "fda"
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28 Sep 2007, 11:18 am
Ironically, within hours of President Bush signing the FDA Amendments Act of 2007 into law, a report is released finding the U.S. [read post]
8 Nov 2013, 11:36 am
Here's the FDA's description:We are proposing to change our regulations to expressly provide that ANDA holders may distribute revised labeling that differs from the RLD upon submission of a CBE-0 supplement to FDA. [read post]
28 Jan 2009, 7:10 am
The NY Times today reports that nine FDA scientists who allege that they were forced to approve medical devices that they did not believe were save now contend that they have become the targets of a criminal investigation. [read post]
5 Jan 2010, 6:45 am
Medical News Today: FDA To Study Safety Of Drugs Taken By Women While Pregnant: The US Food and Drug Administration (FDA) is funding a new programme to study the effects of prescription drugs taken by women while they are pregnant.... [read post]
21 Nov 2022, 2:47 pm
The group complains that the FDA never studied the safety of the drugs under the labeled conditions of use. [read post]
4 Jan 2010, 12:00 am
The Government Accountability Office (GAO) has compiled a report looking at the steps the FDA has been taking to improve communication between the internal offices of the FDA, in an effort to protect the public from dangerous drugs released on the U.S. market. [read post]
15 Jul 2007, 7:02 am
Food and Drug Administration (FDA). [read post]
8 Nov 2018, 9:00 pm
On November 6, the US Food and Drug Administration (FDA) announced that its final guidance on Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff (Mandatory Recall Guidance) is now available. [read post]
6 Oct 2009, 4:16 am
Bloomberg reports that Allergan has sued the FDA and Justice Department challenging FDA rules that prohibit manufacturers from promoting off-label use. [read post]
17 Jul 2015, 12:38 pm
FDA anticipates that the meetings will commence in September or October 2015. [read post]
19 Jun 2017, 7:03 am
Bloomberg News reports that Pfizer received a warning letter from the FDA “after inspectors found ‘significant violations’ at a manufacturing plant for drugs made by its Hospira unit. [read post]
28 May 2009, 4:55 pm
” The FDA group recommended better public information efforts, stronger labels warning of these liver side effects, and does limitations. [read post]
29 Jan 2010, 12:31 pm
From FDA Law Blog: FDA Lays Out Ambitious Agenda in the Latest Draft of its Framework of the Animal Feed Safety System By Ricardo Carvajal & Diane B. [read post]
27 Apr 2021, 10:06 am
FDA: Risk of Stryker STAR Device Failure is Higher for More-Active Patients The FDA notes that the risk of failure is higher for more-active patients. [read post]
27 Apr 2021, 10:06 am
FDA: Risk of Stryker STAR Device Failure is Higher for More-Active Patients The FDA notes that the risk of failure is higher for more-active patients. [read post]
27 Apr 2021, 10:06 am
FDA: Risk of Stryker STAR Device Failure is Higher for More-Active Patients The FDA notes that the risk of failure is higher for more-active patients. [read post]
7 Oct 2006, 5:15 am
Nevertheless, FDA has the authority to inspect their warehouse. [read post]
14 Jul 2010, 4:12 pm
FDA Commissioner Margaret A. [read post]
16 Oct 2015, 8:03 am
The post POGO Says FDA’s Pradaxa Review was “Lax” and “Permissive” appeared first on Legal Reader. [read post]
26 Oct 2023, 9:05 pm
This has led to a movement to “get the F out of the FDA. [read post]
